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Completed

NCT Number: NCT03421704

A Prospective Multicenter Registry of Patients With Sleep Disordered Breathing Treated With DreamStation BiPAP autoSV.

This multi-center observational study will prospectively collect data from patients who have an indication for servo ventilation therapy. This registry is intended to characterize the patient populations that may benefit from DreamStation BiPAP autoSV therapy (PR DS-autoSV, Philips Respironics, Monroeville, PA) in real life settings. In addition, this registry will assess adherence to the PR DS-autoSV therapy, the therapeutic benefits, collect morbidity and mortality data of servo ventilation in patients with central sleep apnea (CSA) and complex sleep-disordered breathing (SDB).

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Key information

Conditions

Central Sleep Apnea Apnea Cheyne-Stokes Respiration Complex Sleep Apnea Dyssomnias Mixed Sleep Apnea Nervous System Diseases Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory Sleep Apnea Syndromes Sleep Apnea, Central Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Universitätsklinikum der Ruhr-Universität Bochum, Bad Oeynhausen, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Indication and prescription of PR DS-autoSV
  • Polysomnographic (PSG) or Polygraphic (PG) documentation of sleep-disordered breathing requiring servo ventilation

Exclusion criteria

  • Patients with HFrEF - heart failure and low ejection fraction (EF ≤ 45%) and predominant CSA (> 50 % of events)
  • Patients not able to receive positive airway pressure support through a mask due to surgical procedure or anatomical condition
  • Chronic conditions with life expectancy < 1 year
  • Significant chronic obstructive pulmonary disease (COPD) with an FEV1/VC < 70% (GOLD III)
  • Respiratory insufficiency requiring long-term oxygen therapy
  • Daytime hypercapnia at rest (pCO2 > 45 mmHg)
  • Cardiac surgery, PCI, myocardial infarction, unstable angina, within 12 weeks prior to enrolment
  • Cardiac resynchronization or pacemaker implantation within the last 6 months
  • Untreated or therapy refractory Restless legs-Syndrome (RLS)

Treatment and study plan

DreamStation BiPAP autoSV

Device

Philips Respironics DreamStation BiPAP autoSV (PR DS-autoSV) is designed to deliver pressure support for patient ventilatory assistance

Primary outcomes

  1. Short term Device usage and therapy adherence

    Time frame: 6 months

    Device usage (hours/ night). Patients will be classified into various adherence subgroups based on the average daily device use at each study interval. The percentage of participants in each of the adherence subgroups will be presented.

Secondary outcomes

  1. Long term Device usage and therapy adherence

    Time frame: 12 months

    EDevice usage (hours/ night). Patients will be classified into various adherence subgroups based on the average daily device use at each study interval. The percentage of participants in each of the adherence subgroups will be presented.

  2. Change in Health-related quality of life

    Time frame: 6, 12 and 24 months

    European Quality of Life-5 Dimensions questionnaire EQ 5D- 5L) is a standardized instrument for measuring generic health related quality of life. This tools scores range from 1 to 5, with higher scores indicating more problems across five dimensions (5D) which comprise mobility, self-care, usual activities, pain/discomfort, and anxiety/depression

  3. Change in Subjective sleep quality

    Time frame: 6, 12 and 24 months

    Pittsburgh Sleep Quality Index (PSQI)

  4. Change in Daytime sleepiness.

    Time frame: 6, 12 and 24 months

    Epworth Sleepiness Scale (ESS). This test consists of eight questions of daily life activities with a number from 0 (not at all likely to fall asleep) to 3 (very likely to fall asleep) which yields a score of 0 to 24, and subjectively quantify sleepiness.25 An ESS score ranging from 0 to 10 is interpreted as normal, scores of 11 to 24 is considered to be abnormal and indicative of increasing levels of excessive daytime sleepiness.

  5. Change on PSG/PG Parameters from baseline

    Time frame: 6 months

    Disordered breathing events

  6. Change on PSG/PG Parameters from baseline

    Time frame: 6 months

    Quality of Sleep

  7. Mortality

    Time frame: 6, 12 and 24 months

    Frequency of death in patients who showed adherence to therapy as compared to those with non-adherence

  8. Causes of death

    Time frame: 6, 12 and 24 months

    causes of death , if available, will be compared in patients who showed adherence to therapy as compared to those with non-adherence

  9. Number of healthcare utilization

    Time frame: 6, 12 and 24 months

    Number of hospitalizations during the minimum of one year follow-up, time to first hospitalization, composite number of unscheduled visits to emergency rooms and/or physician's office) in patients who showed adherence to therapy as compared to those with non-adherence (if data is available)

Sponsors and collaborators

Lead sponsor

Philips Respironics

Industry

Registry information

Acronym: autoSVREGDE

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Feb 5, 2018
Registry last updated
Oct 2, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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